NCT01000896

Brief Summary

The primary purpose of this study is to explore the safety and tolerability of AZD0530 in combination with carboplatin and paclitaxel in Japanese patients with non small cell lung cancer and epithelial ovarian cancer.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_1 cancer

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

8 months

First QC Date

October 14, 2009

Last Update Submit

February 3, 2010

Conditions

CancerNon Small Cell Lung CancerEpithelial Ovarian Cancer

Keywords

Phase Icancersolid tumorsadvanced solid malignanciesNSCLCepithelial ovarian cancerdose escalationcombination treatmentsrc inhibitorJapanese

Outcome Measures

Primary Outcomes (1)

  • Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, general examination, HRCT, SpO2, ECG

    Laboratory assessment prior to chemotherapy administration in all treatment cycles and on days 2, 8 and 15 in cycle 1. General exam, SpO2 and ECG prior to chemotherapy administration in all treatment cycles. HRCT scans performed days 21, 42, 70-98.

Secondary Outcomes (1)

  • Assessment of the pharmacokinetics of AZD0530 (Cssmax, Cssmin, tmax, AUCss0-24, CL/F), its N-desmethyl metabolite M594347 (Cssmax, Cssmin, tmax, AUCss0-24), and carboplatin / paclitaxel (Cmax, AUC, AUC0-t, t1/2, CL and Vss)

    Schedule of PK assessment1. AZD0530/N-desmethyl metabolite M594347Cycle1-day21 -Cycle2-day2; 11point2. carboplatinCycle1-day1 ~ day2; 8 pointCycle2-day1 ~ day2; 8 point3. paclitaxelCycle1-day1 ~day2; 9 pointCycle2-day1 ~ day2; 9 point

Study Arms (1)

AZD0530 + carboplatin and paclitaxel

EXPERIMENTAL

AZD0530 in combination with carboplatin and paclitaxel

Drug: AZD0530Drug: CarboplatinDrug: paclitaxel

Interventions

AZD0530DRUG

film coated tablet, PO, daily

AZD0530 + carboplatin and paclitaxel
CarboplatinDRUG

intravenous, 3 weeks

Also known as: Paraplatin
AZD0530 + carboplatin and paclitaxel
paclitaxelDRUG

intravenous, 3 weeks

Also known as: Taxol
AZD0530 + carboplatin and paclitaxel

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese patients with non small cell lung cancer or epithelial ovarian cancer
  • Must be suitable for treatment with carboplatin and paclitaxel
  • Relatively good overall health other than cancer

You may not qualify if:

  • Poor bone marrow function (not producing enough blood cells).
  • Poor liver or kidney function.
  • Patients unable to discontinue drugs known to be potent inhibitors or inducers of CYP3A4 within 2 weeks prior to registration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Matsuyama, Ehime, Japan

Location

Research Site

Fukuoka, Fukuoka, Japan

Location

MeSH Terms

Conditions

NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian Epithelial

Interventions

saracatinibCarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Mary Stuart

    AstraZeneca

    STUDY DIRECTOR

  • Takashi Seto, MD, PhD

    National Hospital Organisation Kyushu Cancer Centre

    PRINCIPAL INVESTIGATOR

  • Naoyuki Nogami, MD

    National Hospital Organisation Shikoku Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 23, 2009

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

February 4, 2010

Record last verified: 2010-02

Locations

JP(2)